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Labcompliance On-line Audio Seminar

On-line Audio Seminar 103

This seminar has been recorded on a CD. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here

Part 11 Case Studies

The Ultimate Answers and Tools You Need to Define and Document Your Part 11 Scope and Controls

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FDA has made decisions to narrow the scope of part 11. Inspections are coming and inspectors want to know if and how we did implement the narrow scope. Our managers want to have a justification for our part 11 investments. The problem is that many times we really don't know what to do. Good advice is rare and most of the time the answers are: "it depends", "look at the predicate rules", or "make a risk assessment".

Questions are:

  • What is in and what is out of the narrow scope?
  • How to assess the risk of my system?
  • Now I know my system should comply with part 11 but which controls should I implement?
  • What are the real criteria for the various controls like e-audit trail, reprocessing of data, archiving on paper or as e-records
  • How to justify document my decision?
  • Where can I get examples?

How does the audio seminar help:

Step by step instructions will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will use 10+ examples to demonstrate how to make rational decisions on scope and controls. After the seminar, an extensive list of reference material like diagrams, checklists, SOPs and templates will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • Step by step instruction how to justify and document
  • Going through SOPs and templates
  • Practice on 10+ examples from laboratories, offices (Word,Excel), manufacturing, clinical studies
  • Learn how to justify document for your managers
  • Learn how to justify and document for the FDA

And for easy and instant implementation:
download 10+ documents from special seminar website

  • SOPs:
    - Define and document scope and controls for part 11
    - Risk analysis for part 11
    - Training for GxP and Part 11
  • 10 Examples in Powerpoint to illustrate business processes and risks
  • MS Word template to document your decision with examples.
  • Part 11 Gap analysis
  • Biopharm publication: New Scope of Part 11
  • FDA 483 form inspectional observations, establishment inspection reports and several warning letters with deviations related to part 11
  • And more....

Who should attend?

  • Part 11 project managers
  • Members of Part 11 task forces
  • QA managers and personnel
  • Production and lab managers
  • Regulatory affairs
  • Validation specialists
  • Training department
  • Documentation department
  • Consultants

How to order

Pick one of the options in the table that fits your needs. 

Replaced by the more recent seminar

Implementing FDA's 'New' 21 CFR Part 11

Strategies and 10 Case Studies from Manufacturing, Offices and Laboratories

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About audio seminars


Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.